Bloomberg Law tracks recent federal government administrative actions and warnings directed toward pharmaceutical and life sciences entities.
Sharp Drugs Inc., dba Island Drug and Surgical
- Issuing Office: Food and Drug Administration, Division of Pharmaceutical Quality Operations
- Recipient: Joseph Pierro (owner)
- Date: Aug. 2 (posted Sept. 10)
- Inspection of facility in West Hampton Beach, N.Y., July 10-13, 2018
- Drug products intended to be sterile were prepared, packed, or held under insanitary conditions.
- Company failed to perform adequate smoke studies to demonstrate unidirectional airflow within sensitive areas.
- Company failed to perform media fills as required.
- Company informed...